Drug product
Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132
D-582-2013
Product summary
- Firm
- Pentec Health
- Event
- Event 65180
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
drug-enforcement:D-582-2013
Official wording
Reason: Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutritional prescriptions.
Code information: Date: 04/30/13 Discard After: 05/21/13
Distribution pattern: Dialysis Centers Direct to patient
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility